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8 Diseases |  |
17 Trials |
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17 Trials |  |
2602 News |  |
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- || Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal, Real-world evidence: A real-world cohort analysis of alemtuzumab outcomes in relapsing multiple sclerosis. (Pubmed Central) - May 15, 2021
There were no substantial safety issues encountered in our review; rates of adverse events were similar or below those reported in Phase III trials. We compare and contrast our results to other available real-world data using alemtuzumab in multiple sclerosis.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Diffuse alveolar hemorrhage as an early complication of alemtuzumab treatment: A case report of a multiple sclerosis patient and an overview of 14 cases. (Pubmed Central) - May 15, 2021
Importantly, DAH was an early complication. All RRMS patients with known outcome showed complete recovery.
- | Lemtrada (alemtuzumab) / Sanofi
Journal: Systemic erythematous lupus after treatment of multiple sclerosis with alemtuzumab. (Pubmed Central) - May 15, 2021
Her disease remained stable in a follow-up period of over ten years. However, during the follow-up period she developed thyroiditis one year, as well as systemic erythematous lupus seven years after the last alemtuzumab infusion, a disease not previously associated with alemtuzumab administration.
- || Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Clinical, Retrospective data, Journal: Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. (Pubmed Central) - May 15, 2021
P3, P4
Efficacy on relapse, disability, and MRI outcomes continued through Year 8 across age groups. Age-related increases in serious infections, malignancies, and deaths were observed.
- |||| Tysabri (natalizumab) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Clinical: You can only be treated with natalizumab, alemtuzumab or cladribine first-line in England if you have rapidly evolving severe MS or RES-MS. Waiting to become RES is a form of watchful waiting and is clearly a lottery. #ClinicSpeak https://t.co/pJzlRsLobo (Twitter) - May 14, 2021
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, P2 data, Journal: Pregnancy outcomes and postpartum relapse rates in women with RRMS treated with alemtuzumab in the phase 2 and 3 clinical development program over 16 years. (Pubmed Central) - May 11, 2021
P2, P3, P4
Spontaneous abortion rate in alemtuzumab-treated patients was comparable with rates in the general population and treatment-naive MS patients, and was not increased in women with pregnancy onset within 4 months of alemtuzumab exposure. There was a minimal increase in postpartum relapses.
- || Lemtrada (alemtuzumab) / Sanofi
So sad 😞 alemtuzumab saved me early and so many of my ms friends in London. (Twitter) - May 9, 2021
- ||| Lemtrada (alemtuzumab) / Sanofi
“Not getting the wider MS community to understand how effective alemtuzumab is REGRET 4. Instead of success, we have a generation of refuseniks.” #AnyRegrets #ClinicSpeak https://t.co/DvM1s42eAd (Twitter) - May 9, 2021
- |||| Lemtrada (alemtuzumab) / Sanofi
Clinical: #AnyRegrets? Prof G reflects on his career as an MSologist and regrets not doing more to derisk alemtuzumab as first-line therapy for MS. Is it too late? Should he give up and retire to explore safer and greener pastures? #ClinicSpeak https://t.co/DvM1s42eAd (Twitter) - May 8, 2021
- | Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Journal: Alemtuzumab therapy changes immunoglobulin levels in peripheral blood and CSF. (Pubmed Central) - May 7, 2021
There was a minimal increase in postpartum relapses. Our results suggest to monitor IgG levels for safety reasons in patients treated with alemtuzumab-in particular when additional treatment courses are required-and to consider preventive action in critical cases.
- | Lemtrada (alemtuzumab) / Sanofi
Journal: Refractory chronic spontaneous urticaria after the use of alemtuzumab in multiple sclerosis. (Pubmed Central) - May 7, 2021
Our results suggest to monitor IgG levels for safety reasons in patients treated with alemtuzumab-in particular when additional treatment courses are required-and to consider preventive action in critical cases. No abstract available
- || Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Clinical course and outcome of SARS-CoV-2 infection in multiple sclerosis patients treated with disease-modifying therapies - the Polish experience. (Pubmed Central) - May 5, 2021
The hospitalisation rate and the mortality rate were not higher in the MS cohort compared to the general Polish population. Continued multicentre data collection is needed to increase the understanding of SARS-CoV-2 infection impact on the course of MS in patients treated with DMTs.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: A case of lung injury resembling diffuse pulmonary hemorrhage after the first administration of alemtuzumab in a patient with multiple sclerosis. Role of the HRCT. (Pubmed Central) - May 4, 2021
Computed tomography (CT) scan of the chest at the admission showed diffuse and bilateral ground glass pulmonary opacities. Her symptoms resolved completely without any treatment, after the interruption of alemtuzumab, and CT scan of the chest performed one month later showed total disappearance of the pulmonary opacities.
- | Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Journal: Effects of Alemtuzumab on (Auto)antigen-Specific Immune Responses. (Pubmed Central) - May 4, 2021
When we evaluated the number of IFN-γ-secreting cells in relation to the number of present CD4+ T cells, we still found a significant reduction. We conclude that the reduction of IFN-γ-secreting cells by alemtuzumab is not only due to a reduction of the CD4+ T cell fraction within the peripheral blood mononuclear cell (PBMC) compartment but might also be caused by functional changes or a shift in the distribution of different subtypes in the CD4+ T cell pool.
- || Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Review, Journal: Therapeutic Value of Single Nucleotide Polymorphisms on the Efficacy of New Therapies in Patients with Multiple Sclerosis. (Pubmed Central) - May 1, 2021
However, there are few existing studies and their samples are small, making it difficult to generalize the role of these genes in treatment with new therapies. Studies with larger sample sizes and longer follow-up are therefore needed to confirm the results of these studies.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Case Report: Adult Still's Disease in an Alemtuzumab-Treated Multiple Sclerosis Patient. (Pubmed Central) - Apr 29, 2021
Following therapy with rituximab, the patient has fully recovered. The current case highlights AOSD as another rare and potentially life-threatening secondary autoinflammatory/autoimmune event following alemtuzumab treatment.
- | Lemtrada (alemtuzumab) / Sanofi
Trial primary completion date: LemKids: A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT (clinicaltrials.gov) - Apr 22, 2021
P3, N=50, Active, not recruiting, Sponsor: Genzyme, a Sanofi Company
The current case highlights AOSD as another rare and potentially life-threatening secondary autoinflammatory/autoimmune event following alemtuzumab treatment. Trial primary completion date: Dec 2025 --> May 2021
- | Mavenclad (cladribine) / EMD Serono
Trial completion date, Trial primary completion date: DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - Apr 22, 2021
P4, N=800, Recruiting, Sponsor: The Cleveland Clinic
Trial primary completion date: Dec 2025 --> May 2021 Trial completion date: Sep 2023 --> Sep 2026 | Trial primary completion date: Dec 2022 --> Dec 2025
- || Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Lemtrada (alemtuzumab) / Sanofi
Retrospective data, Review, Journal: Disease modifying therapies in relapsing-remitting multiple sclerosis: A systematic review and network meta-analysis. (Pubmed Central) - Apr 22, 2021
More studies are required to explore the long-term effect of DMTs. Our findings could provide helpful information and contribute to clinical treatment decision-making.
- Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Efficacy and Safety of Disease-Modifying Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis- A Systematic Review () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1067;
Of the injectable, infused, and oral DMTs evaluated in this review, all provided a significant clinical benefit for relapse rate reduction. Since comparators differed, further comparison studies are warranted.
- Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] IMMUNOLOGICAL CONSEQUENCES OF IMMUNE ‘RECONSTITUTION’ THERAPY IN MULTIPLE SCLEROSIS: A SYSTEMATIC REVIEW (HALL E) - Apr 11, 2021 - Abstract #AUTO2021AUTO_127;
Additional characterization of the cellular changes occurring during IRT may lead to further improvement in the understanding of the pathogenesis of MS and the future development of therapies with even longer lasting effects. Although the treatments considered in this review improve quality of life and outcomes for patients with MS, a cure for this debilitating disease is not yet in sight.
- || Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Vaccination against SARS-CoV-2 in patients with multiple sclerosis (Pubmed Central) - Apr 10, 2021
The data available make it possible to recommend mRNA vaccines against SARS-CoV-2 in patients with multiple sclerosis. In patients on fingolimod, cladribine, alemtuzumab, ocrelizumab and rituximab, vaccination prior to the initiation of medication administration would be recommendable whenever possible.
- | Lemtrada (alemtuzumab) / Sanofi
Journal: Event-Driven Immunoprofiling Predicts Return of Disease Activity in Alemtuzumab-Treated Multiple Sclerosis. (Pubmed Central) - Apr 7, 2021
This change appears to predict emergent disease activity when compared with stable disease. Studies with larger patient populations are needed to confirm that frequent immunoprofiling may assist in evaluating clinical decision-making of alemtuzumab retreatment.
- | Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab, Lemtrada (alemtuzumab) / Sanofi
Retrospective data, Journal: Comparison of ofatumumab and other disease-modifying therapies for relapsing multiple sclerosis: a network meta-analysis. (Pubmed Central) - Apr 1, 2021
For each outcome, ofatumumab was as effective as other highly efficacious monoclonal antibody DMTs (i.e., alemtuzumab, natalizumab and ocrelizumab). Ofatumumab offers beneficial outcomes for RMS by reducing relapse and disability progression risk.
- | Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Journal: Socioeconomic status and disease-modifying therapy prescribing patterns in people with multiple sclerosis. (Pubmed Central) - Mar 30, 2021
Whilst this appears reassuring within this universal health care setting, the same methodology needs to be applied to other MS services for comparison. Data could then be further interrogated to explore potential socioeconomic inequities in DMT prescribing patterns across the UK.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Inclusion of the Symbol Digit Modalities Test in a revised assessment of 'no evidence of disease activity-4 (NEDA-4)' in Latin-American patients with multiple sclerosis. (Pubmed Central) - Mar 30, 2021
Brain volumetric MRI has yet to be translated into clinical practice and SDMT may qualify as the fourth component of NEDA-4 definition. NEDA-4 has the potential to capture the impact of DMT therapies in RRMS earlier in the disease course of RRMS.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Alemtuzumab and prescription medication use in the MS population. (Pubmed Central) - Mar 30, 2021
Twenty-four percent refilled ≥1 of these prescription(s) after alemtuzumab across 17 drug classes, averaging 0.3 refills/person over 24 weeks. There was substantial medication burden throughout the study.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Review, Journal: Systematic review of gender bias in clinical trials of monoclonal antibodies for the treatment of multiple sclerosis. (Pubmed Central) - Mar 30, 2021
The clinical trials of these 4 monoclonal antibodies present a significant gender bias. In most cases, the primary and secondary endpoints are not analyzed according to patient sex, despite the fact that international recommendations include this as a minimum requirement for ensuring scientific validity and obtaining appropriate results for extrapolation to the wider population.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] A Case of Rare Autoimmune Pancytopenia Due to Graves’ Disease () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3436;
Case Presentation A 54-year-old woman with history of multiple sclerosis on alemtuzumab was referred for abnormal thyroid function tests...Due to leukopenia, the patient was started on propranolol and underwent radioiodine ablation with 14.8 mCI...She was started on prednisone 1 mg/kg/day with resolution of her cytopenias...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Safety of Alemtuzumab and Autologous Hematopoietic Stem Cell Transplantation Compared to Non-induction Therapies for Multiple Sclerosis. (Pubmed Central) - Mar 27, 2021
We confirmed a high incidence of thyroid disease in alemtuzumab- and to a smaller extent also AHSCT-treated patients, and found a higher incidence of infection for AHSCT, compared to both alemtuzumab and non-induction therapies. The incidence of non-thyroid autoimmune disease was low for both therapies.
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal, IO biomarker: Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. (Pubmed Central) - Mar 23, 2021
P3
Several immune measures were identified as possible biomarkers of lesion activity. Future studies are necessary to more precisely define regulatory and effector subsets and their contributions to clinical efficacy and risk for secondary autoimmunity in alemtuzumab-treated patients, and to reveal new insights into mechanisms of immunopathogenesis in MS.
- [VIRTUAL] Industry payments in Neurology Subspecialties: 2014 - 2018 () - Mar 18, 2021 - Abstract #AAN2021AAN_2057;
The introduction of newer medications in a subspecialty coincided with higher industry payments. Identification of these trends and potential motives of the industry spending is critical to address any potential physician bias in prescribing medications.
- Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Short-term evaluation of alemtuzumab to ocrelizumab switch in MS patients with disease activity after alemtuzumab: an Italian multicentric study () - Mar 18, 2021 - Abstract #AAN2021AAN_1718;
Identification of these trends and potential motives of the industry spending is critical to address any potential physician bias in prescribing medications. Short-term FU suggests that the switch to OCR in MS after 2 ALM courses is characterized by a good safety and efficacy profile
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Immune-Mediated Nephropathy after Alemtuzumab () - Mar 18, 2021 - Abstract #AAN2021AAN_1692;
This case highlights a novel but treatable complication of Alemtuzumab and emphasizes the unpredictable timeline of such adverse events. Early diagnosis and initiation of steroids in similar clinical scenarios can prevent long-term decline in renal function.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Scheduled IVIG in Patients Treated with Alemtuzumab Reduces Autoimmune Adverse Reactions () - Mar 18, 2021 - Abstract #AAN2021AAN_1691;
Multiple mechanisms likely contribute to the overall therapeutic effect. IVIG neutralizes autoantibodies and can minimize the release of proinflammatory cytokine signaling from T cells to B cells that secrete autoantibodies.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Alemtuzumab-Induced Intraparenchymal Hemorrhage and Multifocal Dissecting Pseudoaneurysms- A Case Report () - Mar 18, 2021 - Abstract #AAN2021AAN_1683;
Due to its long-term efficacy, repeated infusions are not warranted. The clinical benefit of this agent is limited by its frequent side effects.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Outcomes in Alemtuzumab-Treated Patients With Thyroid Adverse Events: 6-Year Pooled CARE-MS Data () - Mar 18, 2021 - Abstract #AAN2021AAN_1667;
P3
Graves’ disease was considered the most common diagnosis but TSH receptor Ab testing would be required to accurately classify the majority of thyroid AEs. No differences in 6-year MS disease outcomes were seen between patients with and without thyroid AEs.
- Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Clinical Characteristics and Disease Burden of African, Caribbean, and Black People with Multiple Sclerosis in Toronto, Canada () - Mar 18, 2021 - Abstract #AAN2021AAN_1639;
These findings differ from prior studies demonstrating higher MS disease severity in Black and AA MS populations. Differing environmental, genetic, epigenetic and access to healthcare may explain this observed discrepancy, and further study is warranted.
- Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] High and low efficacy therapy in secondary progressive multiple sclerosis () - Mar 18, 2021 - Abstract #AAN2021AAN_1549;
High efficacy DMT is superior to low efficacy therapy in reducing relapse activity in patients with active SPMS, but not those with inactive SPMS. Pre-treatment inflammatory activity, clinical or radiological, is a treatable target in SPMS which may benefit from higher-efficacy anti-inflammatory therapies.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Cases of COVID-19 in Alemtuzumab-Treated Patients With MS: Pharmacovigilance Report () - Mar 18, 2021 - Abstract #AAN2021AAN_1487;
This preliminary COVID-19 case assessment does not suggest any unexpected safety signals in alemtuzumab-treated patients with MS. In-depth analysis is ongoing and will be available at the time of the meeting.
- Lemtrada (alemtuzumab) / Sanofi
[VIRTUAL] Predictive biomarkers to identify an increased risk of autoimmunity in patients treated with alemtuzumab. () - Mar 18, 2021 - Abstract #AAN2021AAN_1477;
In-depth analysis is ongoing and will be available at the time of the meeting. B/4TNF ratio can be a useful tool to stratify the risk of autoimmunity in MS patients who are going to initiate alemtuzumab treatment.
- || Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Role of Monoclonal Antibody "Alemtuzumab" in the Treatment of Multiple Sclerosis. (Pubmed Central) - Mar 18, 2021
It is a point of great concern not only for physicians but also for neurologists, nephrologists, endocrinologists, dermatologists, and oncologists when encountering long-term effects of alemtuzumab in the life of treated MS patients. We hope that our review will not only benefit treating faculties but also those who are suffering from this devastating disease.
- | Campath (alemtuzumab) / Sanofi, Lemtrada (alemtuzumab) / Sanofi
Journal: Spontaneous multiple cervical artery dissections after alemtuzumab. (Pubmed Central) - Mar 16, 2021
In particular, an arterial inflammatory process, secondary to cytokine release, could potentially lead to intimal thickening, luminal irregularities, stenosis, and ultimately occlusion. Occurrence of an unexpected serious adverse event, in our case, multiple cervical artery dissections, especially in a close time window after drug administration, questions a potential causal relationship with the drug or a simple coincidence.
- || Lemtrada (alemtuzumab) / Sanofi
Pity they don’t say the same for lemtrada (in early ms) (Twitter) - Mar 16, 2021
- || Lemtrada (alemtuzumab) / Sanofi
Trial completion: SCALA: A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov) - Mar 10, 2021
P1, N=24, Completed, Sponsor: Genzyme, a Sanofi Company
Occurrence of an unexpected serious adverse event, in our case, multiple cervical artery dissections, especially in a close time window after drug administration, questions a potential causal relationship with the drug or a simple coincidence. Active, not recruiting --> Completed
- || Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Two case reports of acquired haemophilia A as complications of alemtuzumab treatment for multiple sclerosis. (Pubmed Central) - Mar 9, 2021
Acquired haemophilia A is a rare complication following treatment with alemtuzumab. Activated partial thromboplastin time and prothrombin time should be performed in cases of abnormal bleeding in which the platelet count is normal, to facilitate timely diagnosis and prevention of major bleeding complications.
- || Ocrevus (ocrelizumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Lemtrada (alemtuzumab) / Sanofi
Ireland has decided to take anyone with MS off the vaccine priority list unless they’re on ocrevus/rituximab/cladribine/lemtrada. So we’re back of the queue with our age group, despite having low lymphocytes from other dmts. Please send help/strong words to your fellow neuros! (Twitter) - Mar 8, 2021
- || Mavenclad (cladribine) / EMD Serono, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal, HEOR: Cost-effectiveness of cladribine tablets versus fingolimod in patients with highly active relapsing multiple sclerosis in Portugal. (Pubmed Central) - Mar 6, 2021
Hence, it is a dominant strategy in the Portuguese setting. No conclusions can be drawn from the present study regarding other treatment options, in particular natalizumab and alemtuzumab.
- || Lemtrada (alemtuzumab) / Sanofi
Review, Journal: The Meaning of Immune Reconstitution after Alemtuzumab Therapy in Multiple Sclerosis. (Pubmed Central) - Mar 6, 2021
After the robust T and B cell depletion induced by alemtuzumab, the immune system undergoes radical changes during its reconstitution. In this review, we will discuss the current knowledge on the reconstitution of the lymphocyte repertoire after alemtuzumab treatment and how it could affect the development of side effects, which led to its temporary suspension by the European Medical Agency.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Experience in the demyelinating diseases unit of the Hospital de Clínicas Paraguay () - Mar 6, 2021 - Abstract #ACTRIMSForum2021ACTRIMS_Forum_273;
There are no differences in the sex of the patients and the majority are young. The high injury and disability burden on admission tis striking, and the clinical-radiological stability of the patients under treatment with the new DMT throughout the follow-up is notable.